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Treatment With Danazol Before Controlled Ovarian Hyperstimulation in Women With Endometriosis Undergoing IVF


Phase 4
18 Years
40 Years
Open (Enrolling)
Female
Endometriosis, Ovarian Cysts, Infertility

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Trial Information

Treatment With Danazol Before Controlled Ovarian Hyperstimulation in Women With Endometriosis Undergoing IVF


Endometriosis is a chronic benign disease defined by the presence of endometrial tissue
outside the uterine cavity, affecting women in their reproductive age. This disease is
clinically characterized by infertility pelvic pain and the presence of ovarian cysts,
endometriomas, and affects the about 10% of women. Women with endometriosis when undergo IVF
show lower pregnancy rate than general population, and a reduced ovarian reserve, due to the
diseases and often to ovarian surgery. The aim of this study is to evaluate if a
pre-treatment with danazol, an anti-estrogenic agent, may improve the otcome of IVF cycles
in these women


Inclusion Criteria:



- Clinical diagnosis of endometriosis previous laparoscopic surgery for ovarian
endometriotic cysts infertility

Exclusion Criteria:

- age more than 40 years systemic disease antimulleran hormone (AMH)<1 and FSH>20

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

pregnancy rate

Outcome Description:

number of ongoing pregnancy for the number of IVF cycles

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Marco Sbracia, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre for Endocrinology and Reproductive Medicine, Italy

Authority:

Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:

CR-09-2013

NCT ID:

NCT01779232

Start Date:

October 2012

Completion Date:

December 2013

Related Keywords:

  • Endometriosis
  • Ovarian Cysts
  • Infertility
  • endometriosis
  • ivf
  • ovarian reserve
  • danazol
  • Endometriosis
  • Infertility
  • Ovarian Cysts

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